Triggered sacral neuromodulation to treat neurogenic detrusor overactivity based on algorithmic classification of bladder filling status from wireless pressure data.
根据无线压力数据对膀胱充盈状态的算法分类,触发骶神经调节来治疗神经源性逼尿肌过度活动。
基本信息
- 批准号:10317462
- 负责人:
- 金额:--
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2021
- 资助国家:美国
- 起止时间:2021-11-01 至 2024-10-31
- 项目状态:已结题
- 来源:
- 关键词:Activities of Daily LivingAffectAlgorithmsAutonomic DysreflexiaAwarenessBehaviorBladderBotoxCathetersClinicalComputer softwareCustomDataDetectionDiabetic NeuropathiesDisadvantagedDiseaseEffectivenessElderlyEvaluationEventExtravasationFeasibility StudiesFeedbackFemaleFrequenciesFutureGoalsHomeHourHumanIncontinenceIndependent LivingIndividualInjectionsIntestinesKidney FailureLabelLeadMajor Depressive DisorderMeasuresMeta-AnalysisMethodsModelingMultiple SclerosisNerveNerve DegenerationOutcome MeasureParkinson DiseasePeripheralPhasePost-Traumatic Stress DisordersQuestionnairesRadioRattusReadinessRefluxRefractoryReportingResearchResearch Project GrantsRiskSepsisSexual DysfunctionSheepSignal TransductionSocial isolationSpinal cord injuryStrokeSymptomsSystemTechnologyTestingTimeTranslational ResearchTranslationsTreatment EffectivenessUrinary IncontinenceUrinary RetentionUrinary tract infectionUrineUrodynamicsVeteransWomanWorkbaseclassification algorithmcomorbiditydecubitus ulcerdiariesexperiencefall riskfirst-in-humanfunctional declineimplantationimprovedimproved outcomemalemenmilitary serviceneuroregulationpressureresponsesensortooltranslational goaltransmission processtreatment responseurinarywirelesswireless communicationwireless sensor
项目摘要
Neurogenic detrusor overactivity (NDO) resulting from spinal cord injury or disorder (SCI/D) affects 80% of
individuals with SCI/D. It is also associated with peripheral neurodegenerative conditions such as Parkinson’s
disease, multiple sclerosis, diabetic neuropathy, or stroke. NDO causes urinary incontinence that profoundly
impacts dignified, independent living, associates with numerous comorbidities and fall risk, and is a leading
factor in functional decline among the elderly. Urinary incontinence contributes to social isolation and clinical
depression and associates with military service and post-traumatic stress disorder in Veterans.
Restoring urine storage is consistently cited as a high priority by individuals with NDO. Continuous SNM is
an off-label treatment, which is effective for some individuals with NDO. Triggered sacral neuromodulation—in
which SNM is applied only during the portion of the bladder fill cycle where NDO occurs—could show unique
benefit in treatment in some individuals. While triggered SNM increased bladder capacity in sheep and rats,
feasibility has not yet been demonstrated in humans with NDO.
The primary goal of this research is to demonstrate the feasibility of increasing bladder capacity and
reducing bladder filling pressures using triggered SNM in Veterans with NDO. This will expand on unique
technologies developed by our team: the UroMonitor, the Context-Aware Threshold (CAT) algorithm, and the
Application Specific Control Unit (ASCU). The UroMonitor is a small, transurethrally-inserted sensor that
wirelessly transmits bladder pressure data. CAT is a wavelet-based algorithm that detects detrusor
contractions from pressure data in real time. The ASCU is a modular neurostimulation platform supporting
wireless communication and custom control software. We will modify and integrate these technologies to
demonstrate the feasibility of automatically triggering SNM in Veterans. A secondary goal is to use the
UroMonitor to determine bladder capacity, detrusor contraction rate, and filling pressures during a
percutaneous SNM evaluation to identify individuals who respond to SNM therapy before a permanent
implantation. Both translational goals will be accomplished through two Specific Aims (SA):
SA1 will determine the change in bladder response to conditionally-triggered SNM during natural filling
cycles after a two-week sacral neuromodulation evaluation phase in Veterans with NDO. In SA1a we will
integrate a short-range radio and low-power algorithm processor into the ASCU to trigger percutaneous SNM
under algorithm control. In SA1b we will develop and bench-validate a classification algorithm capable of
triggering SNM based on adaptive detection of detrusor contractions. In SA1c we will apply triggered SNM
using data transmitted from the UroMonitor to the ASCU. Triggered SNM will be applied for eight hours at three
timepoints in the two-week percutaneous evaluation phase in eight Veterans. Voided urine volume, time
between voids, and detrusor contraction frequency will be compared to determine change in conditional SNM
response at the two timepoints and compared to baseline. Outcome measures will be measured from validated
questionnaires, catheter-referenced bladder pressures, and collected voided urine.
SA2 will determine change in bladder capacity, filling pressure, and detrusor contraction frequency during
natural filling cycles throughout a two-week continuous sacral neuromodulation evaluation. In SA2a we will
integrate adaptive antennas into the UroMonitor and develop an insertion tool for men and women. SA2b will
demonstrate the feasibility of using the UroMonitor to characterize NDO symptoms (bladder capacity, filling
pressure, and detrusor contraction rate) over several bladder filling/emptying cycles. Eight Veterans will
receive standard, continuous percutaneous SNM for two weeks. NDO symptoms will be measured using the
UroMonitor before SNM and after one and two weeks of continuous SNM. Accuracy of symptom quantification
will be compared to standard catheter-based testing and validated urinary behavior questionnaires.
神经源性逼尿肌过度活动(NDO)是由脊髓损伤或障碍(SCI/D)引起的
项目成果
期刊论文数量(0)
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Steve Majerus其他文献
Steve Majerus的其他文献
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{{ truncateString('Steve Majerus', 18)}}的其他基金
Toward wearable ultrasonic neurostimulation for daily at-home treatment of urinary urge incontinence
用于日常家庭治疗急迫性尿失禁的可穿戴超声神经刺激
- 批准号:
10363621 - 财政年份:2020
- 资助金额:
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